Revised: 10 September 2013
Committees
AGENDA FOR THE 50th MEETING OF THE MEDICINES CLASSIFICATION COMMITTEE TO BE HELD IN THE MEDSAFE BOARDROOM,LEVEL 6, DELOITTE HOUSE, 10 BRANDON STREET, WELLINGTON on TUESDAY 12 NOVEMBER 2013 AT 9:30am AND WEDNESDAY 13 NOVEMBER 2013 AT 9.30am
| 1 |
Welcome |
| 2 |
Apologies |
| 3 |
Confirmation of the minutes of the 49th meeting held on Tuesday 17 JUNE 2013 |
| 4 |
Declaration of conflicts of interest |
| 5 |
Matters arising |
| 5.1 | Objections to recommendations made
at the 49th meeting The deadline for intentions to object to a recommendation made at the 49th meeting, together with a statement of the grounds on which the objection will be made, was 19 August 2013. The Committee will consider any objections raised. |
| 5.2 | Review of the classification criteria As recommended at the 49th meeting, the Committee will consider the draft Medsafe paper How to change the legal classification of a medicine in New Zealand (Microsoft Word document, 433 KB, 13 pages), which includes the revised classification criteria, alongside:
|
| 5.3 | Amyl nitrite - amending the classification
statement to include exempt laboratories Recently, Medsafe has received a number of queries from laboratories that possess sodium cyanide but are exempt from holding a controlled substance license. The laboratories wanted to know how to get a supply of amyl nitrite under the current legislation. Amyl nitrite is currently classified as a prescription medicine; except when sold to a person who holds a controlled substances licence (issued under section 95B of the Hazardous Substances and New Organisms Act 1996) authorising the person to possess cyanide. The Committee will consider amending the classification statement to prescription medicine; except when sold to a person who holds a controlled substances licence (issued under section 95B of the Hazardous Substances and New Organisms Act 1996) authorising the person to possess cyanide; except when sold to an exempt laboratory covered by a Hazardous Substances and New Organisms Act 1996 approved code of practice. Or words of similar meaning. |
| 5.4 | Influenza vaccine - amending the
classification statement from administration by a pharmacist to
include all authorised vaccinators At the 49th meeting, the Committee foreshadowed that the classification of influenza vaccine (as prescription; except when administered to a person aged 18 years or over by a pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health), and potentially Tdap and meningococcal vaccine, should be amended from administration by a pharmacist to include all authorised vaccinators. The Committee will consider amending the classification statement for influenza vaccine, and potentially Tdap and meningococcal vaccine, to include all authorised vaccinators. |
| 5.5 | Naproxen - proposed reclassification
from pharmacy-only medicine to general sale medicine (Naprogesic, Bayer New Zealand Limited) The Committee will reconsider the submission to reclassify naproxen, in solid dose form for oral use containing 220 mg or less per dose form with a recommended daily dose of not more than 660 mg and in a pack containing not more than 15 tablets or capsules, from pharmacy-only medicine to general sale medicine now that further data had been submitted. |
| 5.6 | Matters arising for information |
| 5.6.1 | Reclassification of glycopyrronium
as a prescription medicine only An out-of-session consultation took place in July 2013 regarding the classification of glycopyrronium. Glycopyrronium was classified as:
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| 5.6.2 | Classification of peptide-based
performance and image enhancing drugs As foreshadowed at the 49th meeting, the classifications of the peptide-based performance and image enhancing drugs following further consultation and finalised out-of-session by the Committee, will be presented for information. |
| 6 |
Submissions for reclassification |
| 6.1 | Hyoscine butylbromide - proposed
reclassification from prescription medicine to restricted medicine
(Gastro-Soothe, AFT Pharmaceuticals Limited) This is a company submission (Microsoft Word document, 42 KB, 12 pages) for the reclassification of hyoscine butylbromide 20 mg tablets (Gastro-Soothe), in a pack containing not more than 10 tablets or capsules, from prescription medicine to restricted medicine for the relief of muscle spasm of the gastrointestinal tract. |
| 6.2 | Ibuprofen - proposed reclassification
from pharmacy-only medicine to general sale medicine (Pharmaceutical Solutions in consultation with the New Zealand Retailers Association) This is a submission (Microsoft Word document, 156 KB, 29 pages) for the reclassification of ibuprofen when supplied in liquid form for oral use with a recommended maximum daily dose of not more than 1.2 g, when sold in the manufacturer's original pack containing not more than 4 g of ibuprofen and not more than 100 ml of product and when labelled for use in children from three months, for the relief of pain and reduction of fever or inflammation from pharmacy-only medicine to general sale medicine. |
| 6.3 | Mepyramine - proposed reclassification
from pharmacy-only medicine to general sale medicine (Pharmaceutical Solutions in consultation with the New Zealand Retailers Association) This is a submission (Microsoft Word document, 102 KB, 14 pages) for the reclassification of topical mepyramine, in medicines containing 2% or less, from pharmacy-only medicine to general sale medicine. |
| 6.4 | Omeprazole - proposed reclassification
from pharmacy-only medicine to general sale medicine (Losec, Bayer New Zealand Limited) This is a company submission (Microsoft Word document, 128 KB, 38 pages) for the reclassification of omeprazole, in solid dose form containing 10 mg or less, from pharmacy-only medicine to general sale medicine for the short-term symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and older. |
| 6.5 | Oxymetazoline - proposed reclassification
from pharmacy-only medicine to general sale medicine (Pharmaceutical Solutions in consultation with the New Zealand Retailers Association) This is a submission (Microsoft Word document, 137 KB, 20 pages) for the reclassification of oxymetazoline for nasal use, when labelled for use in adults and children over 6 years of age, from pharmacy-only medicine to general sale medicine. |
| 6.6 | Paracetamol - proposed reclassification
from pharmacy-only medicine to general sale medicine (Pharmaceutical Solutions in consultation with the New Zealand Retailers Association) This is a submission (Microsoft Word document, 130 KB, 21 pages) for the reclassification of paracetamol when supplied in liquid form for oral use and when labelled for use in children from one year and up, from pharmacy-only medicine to general sale medicine. |
| 6.7 | Sildenafil - proposed reclassification
from prescription medicine to restricted medicine (Silvasta, Douglas Pharmaceuticals Limited) This is a company submission (Adobe PDF document, 1,937 KB, 21 pages) for the reclassification of sildenafil 25 mg, 50 mg and 100 mg film coated tablets (Silvasta) from prescription medicine to restricted medicine, when supplied by a pharmacist who has successfully completed the approved training programme and is accredited to supply sildenafil, for the treatment of erectile dysfunction in males aged 35-70 years. |
| 6.8 | Zoster (shingles) vaccine - proposed
reclassification from prescription medicine to prescription medicine
except when… Pharmacybrands Limited) This is a submission (Adobe PDF document, 653 KB, 17 pages) for the reclassification of zoster (shingles) vaccine from prescription medicine to prescription medicine except when administered to a person 50 years of age or over by a registered pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health. |
| 7 | New medicines for classification |
| 8 | Harmonisation of the New Zealand and Australian schedules |
| 8.1 | New chemical entities which are not yet classified in New Zealand |
| 8.2 | Decisions by the Secretary to the Department of Health and Aging in Australia (or the Secretary's Delegate) |
| 8.2.1 | Decisions by the Delegate - March
2013 To be considered under agenda item 8.1. |
| 8.2.2 | Decisions by the Delegate - June
2013 To be considered under agenda item 8.1. |
| 9 | Agenda items for the next meeting |
| 10 | General business |
| 11 | Date of next meeting |
